drugset / Trial / NCT06167317
Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors
Non-randomizedSequentialOpen-labelTreatment
Summary
The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-0201 when given alone or in combination with sacituzumab govitecan (SG) in participants with advanced solid tumors. The primary objectives of this study are to: * To assess the safety and tolerability of GS-0201 as monotherapy and in combination with SG in participants with selected advanced solid tumors * To identify the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of GS-0201 as monotherapy and the MTD and/or the RP2D and dosing schedule of GS-0201 in combination with SG in participants with selected advanced solid tumors
Timeline
- Start
- 2024-01-09
- Primary completion
- 2028-09
- Completion
- 2028-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GS-0201 | Unknown | — | Oral |
| Subject | Sacituzumab Govitecan | Monoclonal antibody | — | Intravenous |